NCT04962165

Brief Summary

The prevalence of obstructive sleep apnea (OSA) is a significantly higher in people after spinal cord injury (SCI) than in the general population. As a positive pressure therapy (CPAP) is often poorly tolerated, a mandibular advancement device (MAD) can be used for the treatment of OSA. The purpose of this study is to determine the efficacy of MAD in people with SCI and to verify their adherence to the therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

January 7, 2021

Last Update Submit

March 12, 2023

Conditions

Obstructive Sleep ApneaSpinal Cord Injuries

Keywords

ApneaSpinal cord injuryMandibular Advancement Device

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea index (AHI)

    The obstructive Apnea-Hypopnea Index is defined as the mean number of obstructive apneas and hypopneas per hour of sleep, thus: the occurrence of 5 to 14 events per hour of sleep means presence of mild apnea, 15 to 29 moderate apnea and ≥ 30 severe apnea. The AHI is derived from overnight polygraphy.

    through study completion, an average of 6 month

Secondary Outcomes (2)

  • Daytime sleepiness

    through study completion, an average of 6 month

  • Quality of life measurement

    through study completion, an average of 6 month

Study Arms (1)

Experimental group

EXPERIMENTAL

The group of SCI people will use a mandibular advancement device for treatment of obstructive sleep apnea.

Device: Mandibular Advancement Device

Interventions

Mandibular Advancement DeviceDEVICE

The device maintain opened upper airway by moving the lower jaw slightly forward while sleeping.

Experimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI \> 5 on polygraphy
  • sufficient set of teeth to hold a splint
  • written informed consent

You may not qualify if:

  • use of medication that could affect breathing or sleep
  • oxygen-dependent or decompensated lung disease
  • decompensated congestive heart failure
  • evidence of other sleep disorders (narcolepsy, restless legs syndrome, insomnia)
  • abnormalities of the upper airway
  • periodontal problems and untreated caries
  • mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paraple Center - rehab center for SCI people

Prague, 150 06, Czechia

RECRUITING

Related Publications (3)

  • Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.

    PMID: 31717429BACKGROUND

  • Graco M, Schembri R, Cross S, Thiyagarajan C, Shafazand S, Ayas NT, Nash MS, Vu VH, Ruehland WR, Chai-Coetzer CL, Rochford P, Churchward T, Green SE, Berlowitz DJ. Diagnostic accuracy of a two-stage model for detecting obstructive sleep apnoea in chronic tetraplegia. Thorax. 2018 Sep;73(9):864-871. doi: 10.1136/thoraxjnl-2017-211131. Epub 2018 May 7.

    PMID: 29735608BACKGROUND

  • Kriz J., Kyselova A., Sever D. Sleep Apnea In Patients With Chronic Spinal Cord Injury. Abstractbook. The 4th ISCoS and ASIA Joint Scientific Meeting, May 14-16, 2015, Montreal, Canada.

    BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSpinal Cord InjuriesApnea

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Jiri Kriz, MD, PhD

    Spinal Cord Unit, University Hospital Motol

    STUDY DIRECTOR

Central Study Contacts

Lenka Honzatkova, MSc

CONTACT

+420274771478honzatkova@paraple.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

July 14, 2021

Study Start

August 1, 2021

Primary Completion

June 30, 2023

Study Completion

November 30, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

CZ(1)